Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection (Pro-SEPS)
A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.
The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.
This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)
140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.
The primary outcome is the rate of patients undergoing antibiotic treatment at D5.
Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.
Duration of patient enrollment is 30 days.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection|
- rate of patients undergoing antibiotic treatment at D5. [ Time Frame: at D5 ] [ Designated as safety issue: Yes ]
- evolution of the SOFA score between D0, D3 and D5. [ Time Frame: D30 ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
duration of the antibiotic treatment guided by procalcitonin level
Other: Procalcitonin level
The duration of antibiotic treatment is based on PCT level:
No Intervention: physician's appreciation
duration of the antibiotic treatment based on physician's appreciation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025180
|ICU in J.Minjoz hospital|
|Besançon, France, 25030|
|ICU in Avicenne hospital|
|Bobigny, France, 93009|
|ICU in Ambroise Paré hospital|
|Boulogne, France, 92100|
|ICU in Raymond Poincaré hospital|
|Garches, France, 92380|
|ICU in André Boulloche hospital|
|Montbeliard, France, 25200|
|ICU in Centre hospitalier général|
|Mulhouse Belfort, France, 90000|
|ICU in St Etienne hospital|
|St Etienne, France, 42055|
|ICU in Purpan hospital|
|Toulouse, France, 31059|
|ICU in Rangueil hospital|
|Toulouse, France, 31059|
|Principal Investigator:||Djillali Annane, Professor||Raymond Poincaré hospital Garches-France|